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FDA 510(k)

MINIMED INSULIN PUMP, MODEL 505

K-Number: K963948 · 1997-04-08

ApplicantMedtronic Minimed
Decision Date1997-04-08
Product CodeLZG
Advisory CommitteeHO
DecisionSubstantially Equivalent - Subject to Tracking Reg.

Device Summary

MINIMED INSULIN PUMP, MODEL 505 is the device name listed in this FDA 510(k) record. The listed applicant is Medtronic Minimed. It received FDA 510(k) clearance on 1997-04-08 under 510(k) number K963948. The device is classified under product code LZG. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent - Subject to Tracking Reg..

Frequently Asked Questions

What is the MINIMED INSULIN PUMP, MODEL 505?

MINIMED INSULIN PUMP, MODEL 505 is a medical device that received FDA 510(k) clearance on 1997-04-08. The listed applicant is Medtronic Minimed. The 510(k) number is K963948.

When did MINIMED INSULIN PUMP, MODEL 505 receive FDA 510(k) clearance?

MINIMED INSULIN PUMP, MODEL 505 received FDA 510(k) clearance on 1997-04-08, under 510(k) number K963948.

Who is the listed applicant for MINIMED INSULIN PUMP, MODEL 505?

The FDA 510(k) record lists Medtronic Minimed as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for MINIMED INSULIN PUMP, MODEL 505?

The FDA product code for MINIMED INSULIN PUMP, MODEL 505 is LZG.

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Other records listing Medtronic Minimed as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K261962SmartGuard Technology; Predictive Low Glucose TechnologyK253701SmartGuard Technology; Predictive Low Glucose TechnologyK253512MiniMed Go AppK242775InPen System App (MMT-8060 (iOS), MMT-8061 (Android))K241622Extended Reservoir; MiniMed ReservoirK160860MiniMed Quick-serter

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Related Devices (Code: LZG)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K262153Pivot Insulin Delivery SystemModular Medical, Inc.K253534Pivot Insulin Delivery SystemModular MedicalK240158Modular Medical MODD1 Insulin Delivery SystemModular Medical, Inc.K241622Extended Reservoir; MiniMed ReservoirMedtronic MinimedK223372Omnipod GO Insulin Delivery DeviceInsulet CorporationK210714Extended ReservoirMedtronic Minimed, Inc.

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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